🍊Our mission
All new medicines need to undergo clinical trials to show they’re safe and effective. But today’s clinical trial infrastructure is stuck in the past, and the cost of developing new medicines has skyrocketed as a result. Patients have to wait longer and pay more for new treatments.
Our mission is to fix this; we use software to help innovative companies run faster, more reliable, and patient-friendly clinical trials. We’re still a young company, but we’ve already had a big impact. Since founding the company in March 2021 we’ve helped run over 100 clinical trials involving tens of thousands of patients, with a customer NPS of 100.
We recently raised a $55m Series B round from Balderton Capital, with support from Creandum, Firstminute, Seedcamp, and Visionaries.
The primary responsibility of the Senior Trial Manager is the management and delivery of clinical trials to our German clients. As one of Lindus Health's team members; teamwork, integrity and high agency are absolutely essential. A good working knowledge of the regulatory, ethics and clinical operations requirements is a prerequisite. You will be required to work and contribute in an agile and innovative work culture.
🍊About you
We'd like to hear from you if...
You have meaningful experience working on German clinical trials and are business proficient in speaking German
You can evidence a strong knowledge of Good Clinical Practice/ICH guidelines, regulatory requirements, drug development process and clinical monitoring procedures
You have >4 years' experience of end to end management and co-ordination of clinical trials in a project management and/or clinical operations role
You're experienced in study start-up and EC/IRB applications
You've used different software for delivery of clinical trials and are able to adapt to using new technology to change the way trial processes are delivered
You've worked on and have a strong understanding decentralised/remote trials
You've run multi-site and IND/CTIMP trials
Experience of working in a startup/biotech is a plus
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🍊What you'll focus on
Project Leadership and Delivery:
Lead and manage the day to day running of CTIMP and non-CTIMP clinical trial programs and projects, ensuring that they delivery successfully (i.e., conduct trials on time, on budget, in compliance, and of high quality)
Act as the primary liaison between Lindus Health and the Sponsor to ensure project launch, conduct, and closeout according to the Sponsor’s and Lindus health's contractual agreement
Coordinate activities and deliverables of all project partners and proactively identify and manage issues
Reporting and Communication:
Accountable for the maintenance of project information on a variety of databases and systems
Maintain and evaluate project progress by maintaining the timeline and other tracking/analysis tools
Responsible for the project management components of inspection readiness for all aspects of the project conduct, including Trial Master Files
Provide oversight for the development and implementation of project plans in accordance with Lindus Health's standard operating procedures
Direct the activities of the assigned Project Support staff and mentor other project management team members and clinical staff; facilitate team building and communication
Develops contingency planning and risk mitigation strategies to ensure successful delivery of project goals
Training:
Facilitate team training in accordance with protocol and/or project requirements, including therapeutic, protocol specific, and process training
Collaboration:
Work closely with the tech and product teams to help design best-in-class trial technology that exceeds customer demands (e.g., EDC, e-Consent, eTMF)
Collaborate with Quality Management to develop formal study requirements that enable rigorous validation of clinical trial software, and contribute to the development and maintenance of our standard operating procedures and policies
Business development:
Support business development work with Sponsors and vendors where necessary
🍊What we offer
Unlimited holidays; everyone is encouraged to take off at least 28 days each year
60 EUR monthly wellness allowance, which you can spend on a wellhub membership, or wellness activities and expenses of your choice!
Enhanced Parental Leave: 16 weeks full pay for primary caregiver and 6 weeks full pay for secondary caregiver
1000 EUR Learning and Development allowance each year to put towards courses, certifications, and development
Regular whole company and team events, both in person and virtually.
Access to gym and retail discounts through our benefits platform Happl
Monthly lunch voucher for our remote teams
Charity events and fundraising opportunities through our charity partnership with the Forward Trust
🍊Our hiring process
Initial interview with Sarah, (Talent Partner) (15 mins)
Second meeting with a member of the Clinical Operations Team (30 mins)
Interview with 2 members of the Clinical Operations team (45 mins)
Values interview with one of our Co-Founders and one additional team member (30 mins)
Germany
